CN-121985912-A - Sampling device recommendation based on target location

CN121985912ACN 121985912 ACN121985912 ACN 121985912ACN-121985912-A

Abstract

Systems, devices, and methods for determining a sampling device for use in an ultrasound-guided endoscopic tissue acquisition procedure are disclosed. An exemplary system includes an ultrasound imaging device for generating an ultrasound image of an anatomical object in a real-time ultrasound field of view (FOV), a display for displaying the ultrasound image in the ultrasound FOV, and a processor. Based on the position of the anatomical object in the ultrasound FOV, the processor predicts a nominal sampling device trajectory intersecting the anatomical object from a plurality of nominal sampling device trajectories. The plurality of nominal trajectories corresponds to different hardware configurations of the plurality of nominal sampling devices. The processor determines a sampling device recommendation having a hardware configuration based on the predicted nominal sampling device trajectory.

Inventors

Vignesh Mandarapapupati
Joshua Michael. Adler
Richard. Rhodes
Michael. Cicero

Assignees

韦兰医疗技术有限责任公司

Dates

Publication Date: 20260505
Application Date: 20240905
Priority Date: 20230907

Claims (20)

1. A system for determining a sampling device for use in a medical procedure of a patient, the system comprising: an ultrasound imaging device configured to generate an ultrasound image of an anatomical object in a real-time ultrasound field of view (FOV) of a region of interest; a display configured to display the ultrasound image in the real-time ultrasound FOV, and The processor may be configured to perform the steps of, the processor is configured to: receiving an indication of a position of the anatomical object within the real-time ultrasound FOV; Predicting a nominal sampling device trajectory intersecting the anatomical object within the real-time ultrasound FOV from a plurality of nominal sampling device trajectories, the plurality of nominal sampling device trajectories corresponding to respective hardware configurations of a plurality of sampling devices, based at least in part on the received indication of the position of the anatomical object, and A recommended sampling device for sampling tissue from the anatomical object is determined, the recommended sampling device having a hardware configuration according to the predicted nominal sampling device trajectory.
2. The system of claim 1, wherein the recommended sampling device comprises a recommended intrabronchial needle for sampling tissue from a lung peripheral target during an intrabronchial ultrasound-guided transbronchial fine needle aspiration (EBUS-TBNA) procedure.
3. The system of claim 1, wherein the recommended sampling device comprises a needle-core combination comprising a needle and a core insertable into the needle, wherein one or more of the core or the needle has a preformed curvature or bending angle that substantially conforms to the predicted nominal sampling device trajectory.
4. The system of claim 1, wherein the display is further configured to display one or more of the following within the real-time ultrasound FOV: A graphical representation of the plurality of nominal sampling device trajectories; The indication of the location of the anatomical target; An indication of the predicted nominal sampling device trajectory, or Information about the recommended sampling device.
5. The system of claim 1, wherein each of the plurality of nominal sampling device trajectories is color coded to match a corresponding color code of the plurality of sampling devices, Wherein the predicted nominal sampling device trajectory is color coded to match the color code of the recommended sampling device.
6. The system of claim 1, wherein the respective hardware configurations of the plurality of sampling devices comprise respective different pre-formed curvatures or bending angles, Wherein the recommended sampling device is selected from the plurality of sampling devices and has a preformed curvature or bend angle that substantially conforms to the predicted nominal sampling device trajectory.
7. The system of claim 1, wherein the processor is configured to: receiving user input identifying the anatomical object within the real-time ultrasound FOV via a user interface, and The ultrasound images within the real-time ultrasound FOV are analyzed to determine a location of the anatomical object identified by the user.
8. The system of claim 1, wherein the processor is further configured to generate a recommendation for repositioning one or more of the sampling device or the ultrasound imaging device to align the anatomical target with the predicted nominal trajectory of the sampling device.
9. The system of claim 6, wherein the recommending comprises advancing, retracting, or rotating the ultrasound imaging device a specified amount to align the anatomical target with the predicted nominal sampling device trajectory.
10. The system of claim 1, wherein the ultrasound imaging device is located at a distal end of an intra-bronchial sampling device configured to be inserted into an airway of a patient during an intra-bronchial ultrasound-guided transbronchial fine needle aspiration (EBUS-TBNA) procedure.
11. An intraluminal imaging device system, comprising: An intraluminal imaging device comprising a tubular device body having a lumen and a side outlet port, and an ultrasound transducer configured to generate an ultrasound scan of an anatomical target and generate an ultrasound image in a real-time ultrasound field of view (FOV) of a region of interest; A display configured to display a graphical representation of the ultrasound image and a plurality of nominal sampling device trajectories traversing the FOV in the real-time ultrasound FOV, and A tissue sampling device configured to be operable under ultrasound guidance: Through the lumen and out of the side outlet port of the tubular device body, and Advancing toward and then intersecting the anatomical target according to a predicted nominal trajectory selected from the plurality of nominal sampling device trajectories, Wherein the plurality of nominal sampling device traces correspond to respective hardware configurations of a plurality of sampling devices, Wherein the tissue sampling device has a hardware configuration corresponding to the predicted nominal trajectory.
12. The intraluminal imaging device system of claim 11, wherein the tissue sampling device comprises an intrabronchial needle for sampling tissue from a lung peripheral target during an intrabronchial ultrasound guided transbronchial fine needle aspiration (EBUS-TBNA) procedure.
13. The intraluminal imaging device system of claim 11, wherein the tissue sampling device comprises a needle-core combination comprising a needle and a core insertable into the needle, wherein one or more of the core or the needle has a preformed curvature or bend angle that substantially conforms to the predicted nominal sampling device trajectory.
14. The intraluminal imaging device system of claim 11, wherein the plurality of nominal sampling device trajectories are each color coded to match a respective color code of the plurality of sampling devices, Wherein the predicted nominal trajectory is color coded to match the color code of the tissue sampling device.
15. The intraluminal imaging device system of claim 11, wherein the respective hardware configurations of the plurality of sampling devices comprise respective different preformed curvatures or bending angles, Wherein the tissue sampling device has a preformed curvature or bend angle that substantially conforms to the predicted nominal sampling device trajectory.
16. The intraluminal imaging device system of claim 11, wherein the intraluminal imaging device comprises a bronchoscope configured to be inserted into an airway of a patient during an intrabronchial ultrasound guided transbronchial fine needle aspiration (EBUS-TBNA) procedure, the ultrasound transducer being located at a distal end of the bronchoscope.
17. A method for determining a sampling device for use in a medical procedure, the method comprising: Displaying an ultrasound image of the anatomical object in a real-time ultrasound field of view (FOV) of the region of interest via a graphical user interface; receiving, via the graphical user interface, a selection of the anatomical target within the ultrasound image; determining a position of the anatomical object within the real-time ultrasound FOV; Predicting a nominal sampling device trajectory intersecting the anatomical object within the real-time ultrasound FOV from a plurality of nominal sampling device trajectories, based at least in part on the determined position of the anatomical object, the plurality of nominal sampling device trajectories corresponding to respective hardware configurations of a plurality of sampling devices, and A recommended sampling device for sampling tissue from the anatomical object is determined, the recommended sampling device having a hardware configuration according to the predicted nominal sampling device trajectory.
18. The method of claim 17, further comprising displaying, via the graphical user interface and within the real-time ultrasound FOV, one or more of: A graphical representation of the plurality of nominal sampling device trajectories; the location of the anatomical target; An indication of the predicted nominal sampling device trajectory, or Information about the recommended sampling device.
19. The method of claim 17, wherein each of the plurality of nominal sampling device trajectories is color coded to match a corresponding color code of the plurality of sampling devices, Wherein the predicted nominal sampling device trajectory is color coded to match the color code of the recommended sampling device.
20. The method of claim 17, wherein the respective hardware configurations of the plurality of sampling devices comprise respective different pre-formed curvatures or bending angles, Wherein the recommended sampling device is selected from the plurality of sampling devices and has a preformed curvature or bend angle that substantially conforms to the predicted nominal sampling device trajectory.

Description

Sampling device recommendation based on target location Priority statement The present application claims priority from U.S. provisional patent application serial No. 63/581,080, filed on 7 of 9 of 2023, and U.S. provisional patent application serial No. 63/607,643, filed on 8 of 12 of 2023, the contents of both of which are incorporated herein by reference. Technical Field This document relates generally to ultrasound devices and, more particularly, but not by way of limitation, to ultrasound-guided tissue acquisition devices including a graphical user interface for assisting tissue sampling device selection and tissue sampling process planning. Background Endoscopes have been used in a variety of clinical procedures including, for example, illumination, imaging, detection and diagnosis of one or more disease states, providing fluid delivery toward an anatomical region (e.g., saline or other agents via a fluid channel), providing a channel (e.g., via a working channel) for collection of tissue samples from anatomical targets by a tissue sampling device or biopsy device or for medical diagnosis or treatment by a diagnostic device or treatment device, or providing an aspiration channel for collection of fluid and unwanted objects (e.g., tissue or stone structures) from an anatomical region, among other procedures. Anatomical regions or targets to be intervened include the gastrointestinal tract, respiratory tract and lungs, organs and tissues of the renal system, sinus cavities, submucosal regions, genital organs, and the like. Some endoscopes may be used with an energy source (e.g., a laser system or a plasma system) to provide therapeutic energy (e.g., laser pulses) to an anatomical target (e.g., soft or hard tissue or a lithiasis structure) to achieve various therapeutic targets. For example, endoscopic lasers have been used in applications including tissue ablation, coagulation, vaporization, fragmentation and lithotripsy to break down stones in the kidneys, gall bladder, ureters and other stone forming areas, or to ablate large stones into smaller fragments. Endoscopic Ultrasound (EUS) is a specialized type of endoscopy that combines conventional endoscopy with ultrasound imaging to obtain ultrasound images of anatomical objects or regions of interest. Such specialized endoscopes, also known as echogenic endoscopes, include an ultrasound transducer typically located at a distal portion of an elongate endoscope body. The ultrasound transducer emits ultrasound waves toward the anatomical target and converts the ultrasound echoes into ultrasound images (e.g., a real-time image stream). EUS has been used in diagnosing pulmonary diseases. Endobronchial ultrasound (EBUS) is a minimally invasive and efficient procedure for diagnosing lung cancer, infections, and other diseases that result in breast lymphadenectasis. EBUS is typically performed using a dedicated bronchoscope associated with an ultrasound transducer or removable ultrasound probe that is delivered through a working channel and expelled from a port located at the distal end of the bronchoscope. EBUS has been used in tissue sampling or biopsy procedures (known as intrabronchial ultrasound guided transbronchial fine needle aspiration (EBUS-TBNA) procedures) in which a dedicated sampling device (e.g., biopsy needle) may be passed down and then extended from a bronchoscope, and guided in real time by the EBUS, to collect tissue samples from peribronchial bumps (e.g., peribronchial nodules) or from peribronchial lymph nodes. The sampled tissue may be analyzed to aid in diagnosing various diseases, such as tuberculosis, sarcoidosis, or cancer. Disclosure of Invention The present inventors have recognized several technical problems to be solved with conventional EUS systems and techniques, particularly those associated with the EBUS-TBNA process. One such technical problem is that existing intrabronchial sampling devices are typically designed for procedures involving shallow and large diameter airways of the respiratory system in which the clinician is free to advance, retract or tilt a transbronchial aspiration or sampling device (e.g., needle) to align with a nominal trajectory. The sampling device may be maneuvered to follow a nominal trajectory and eventually intersect an anatomical object of interest (e.g., peribronchial nodules). However, existing intrabronchial sampling devices are generally not designed (and thus may not be ideal) for collecting tissue samples from targets located deep in the peripheral region of the lung (e.g., primary, secondary, or tertiary bronchi or bronchioles), which can only be accessed via very distal and stenotic airways. As the Inner Diameter (ID) of the airway decreases toward the tip, the distance that the sampling device can extend into the airway is typically limited by the ID of the airway and the Outer Diameter (OD) of the sampling device. If the target nodule becomes clearly imaged at a location below some nomi